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Completed

NCT Number: NCT05039749

Human Centric Lighting to Improve Patient Sleep Parameters

Human centric lighting (HCL) is a technology that supports the body's circadian rhythm, as it can stimulate the sleep triggering hormone, melatonin, to improve sleep hygiene over standard lighting (SL), and promote recuperative sleep for a timely return-to-duty. In intensive care units, exposure to HCL has improved sleep measures. However, the effect in the medical surgical (MS) environment is unknown. The purpose of this study is to assess the feasibility of study procedures in MS setting and conduct a preliminary evaluation of the effect of light on inpatient sleep. Recruitment started November 2020 through April 2021. Data analysis is pending.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landstuhl Regional Medical Center

Landstuhl, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who is an active duty service member, GS Civilian, Dependent or Retiree affiliated with the Army, Air Force or Navy.
  • Patient who is informed by provider or anticipates being admitted for at least two nights.
  • Patient who can read and speak English fluently (since surveys are not translated in any other language).

Exclusion criteria

  • Patient with visual impairment which cannot be corrected with glasses or contact lenses such as complete blindness, (defined as inability to see light), or partial blindness (defined as very limited vision) such as patients with history of cataracts.
  • Patient taking an oral medication for sleep.
  • Patient receiving radioactive ionization treatment.
  • Patient who requires isolation or palliative care.
  • Patient recovering from head/neck or oral maxillofacial surgery that would impede saliva sample collection (i.e. jaw wiring, extensive gauze packing in oral cavity)
  • Patient who reports status as a Department of Defense Contractor at screening.

Treatment and study plan

Human Centric Lights

Device

Bright light is emitted during the day from 06:00, then auto-dimmed light is used at night, beginning 19:00.

Primary outcomes

  1. Total Sleep Time

    Time frame: During participant's inpatient stay, not to exceed 5 days.

    Assess the feasibility of measuring total sleep time in MS setting, using an actigraphy device.

  2. Sleep Efficiency

    Time frame: During participant's inpatient stay, not to exceed 5 days.

    Assess the feasibility of measuring sleep efficiency in MS setting, using an actigraphy device.

  3. Sleep Patterns

    Time frame: During participant's inpatient stay, not to exceed 5 days.

    Assess the feasibility of assessing sleep patterns in MS setting, using a Consensus Sleep Diary (CSD).

  4. Dim Light Melatonin Onset - collection

    Time frame: During participant's inpatient stay, not to exceed 5 days.

    Assess the feasibility of collecting samples to assess dim light melatonin onset in MS setting, using passive drool saliva sampling.

  5. Patient experience

    Time frame: One time - approximately a 5 to 15 minute interview

    Describe the patient's experience of participating in the study, in a MS setting, using a semi-structured interview (SSI).

Secondary outcomes

  1. Dim Light Melatonin Onset - analysis

    Time frame: Collected during participant's inpatient stay, not to exceed 5 days.

    Conduct a preliminary evaluation of the effect of light on inpatient sleep using dim light melatonin onset saliva sampling.

Sponsors and collaborators

Lead sponsor

Landstuhl Regional Medical Center

Fed

Collaborators

  • TriService Nursing Research Program

Registry information

Official study title

Human Centric Lighting to Improve Patient Sleep Parameters: A Feasibility Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2021
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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